ARDSNCT06511622
Impact of Immune Status on Secondary Infections in Patients With Acute Respiratory Failure
An observational study of ARDS, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This is a retrospective observational study over the period 1/2019 - 02/2024 with the aim of identifying patients with a predisposition to secondary infections. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- ARDS
- How many people
- 686 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jul 2024to 18 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female patients who received intensive care treatment for acute respiratory distress syndrome on ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days.
Who may be able to join
- Male and female acute respiratory distress syndrome patients who had an immune status within 48 h of admission
- Patients who received intensive care treatment for acute respiratory distress syndrome ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin
Berlin, 10117
About this study
This is a retrospective observational study over the period 1/2019 - 02/2024 with the aim of identifying patients with a predisposition to secondary infections.
Read the detailed description
As a reference center, Charité Universitaetsmedizin Berlin has been treating patients with the most severe form of acute respiratory failure, known as acute respiratory distress syndrome (ARDS), for more than 30 years. Despite lung-protective forms of ventilation and the use of extracorporeal procedures for oxygenation and decarboxylation (ECMO), mortality is around forty percent. In addition to the primary cause of ARDS, further infectious complications often develop during the course of the disease, which delay recovery.
The aim of this study is to investigate infectious complications (ventilator-associated pneumonia, reactivation of Herpes viridae, pathogen resistance despite formally correct therapy, fungal infections) depending on the immune status.
- Conditions
- ARDS
- Keywords
- ARDS, ECMO, Herpes viridae
What is being measured
The primary outcome is the main question the study is designed to answer.
Herpes simplex reactivation
semi-quantitatively with Herpes simplex (negative / slightly positive / positive and strongly positive) in blood or bronchial lavage
Measured: 01/2019- 12/2025
Cytomegalovirus reactivation
as absolute copy number per milliliter of blood or bronchioalveolar lavage
Measured: 01/2019- 12/2025
Epstein Barr virus reactivation
absolute copy number per milliliter of blood or bronchioalveolar lavage
Measured: 01/2019- 12/2025
B cells (CD19 positive)
Absolute number per nanoliter and percentage of lymphocytes
Measured: 01/2019- 12/2025
Natural killer cells Cells (CD16 pos)
Absolute number per nanoliter and percentage of lymphocytes.
Measured: 01/2019- 12/2025
T helper cells (CD4)
Aabsolute number per nanoliter and percentage of lymphocytes
Measured: 01/2019- 12/2025
Cytotoxic T cells (CD8)
Absolute number per nanoliter and percentage of lymphocytes
Measured: 01/2019- 12/2025
HLA-DR expression on monocytes
in molecules per cell
Measured: 01/2019- 12/2025
Secondary outcomes (18)
Beginn weaning
Days until the first successful spontaneous breathing trial.
Measured: 01/2019- 12/2025
Extracorporeal membrane oxygenation duration
Extracorporeal membrane oxygenation is measured in days
Measured: 01/2019- 12/2025
Costs of treatment
Costs of treatment are measured by costs of particular microbiological diagnostics and therapy.
Measured: 01/2019- 12/2025
Pathogen persistence after guideline-compliant therapy (yes/no)
Measured: 01/2019- 12/2025
Ventilator-associated pneumonia (yes/no)
Measured: 01/2019- 12/2025
Occurrence of fungal pneumonia (yes/no)
Measured: 01/2019- 12/2025
Mortality
ITS mortality and hospital mortality are measured.
Measured: 01/2019- 12/2025
Sequential Organ Failure Assessment (SOFA score)
Routine patient treatment data - score is measured numerically (0 - 24) Routine patient treatment data.
Measured: 01/2019- 12/2025
Simplified Acute Physiology Score (SAPS II)
Routine patient treatment data - score is measured numerically (0 - 163)
Measured: 01/2019- 12/2025
Pre-existing conditions
Classified recording of previous illnesses (e.g. haematological diseases, tumour diseases, chronic heart failure, etc.) from the medical file.
Measured: 01/2019- 12/2025
Concomitant infections with therapy
Results of microbiological diagnostics (growth- and molecular-based diagnostics) by specifying the name of the pathogen.
Measured: 01/2019- 12/2025
Volumes
Volumes administered, incl. transfusions and coagulation factors
Measured: 01/2019- 12/2025
Ventilation parameters
Recording of ventilation parameters such as airway, ventilation mode and start of ventilation weaning.
Measured: 01/2019- 12/2025
Catecholamine doses
Name of catecholamines, inotropes and vasopressors
Measured: 01/2019- 12/2025
Number of catecholamine days
Number of days with dose of norepinephrine > 0.1 µg/kg/min for more than 30 min or equivalent dose of other catecholamines.
Measured: 01/2019- 12/2025
Recording of end organ damage such as liver and kidney failure
Organ damage measured by routine laboratory
Measured: 01/2019- 12/2025
Diagnoses during the intensive care stay
Diagnoses as the cause of ARDS, but also newly acquired diagnoses such as critical illness myopathy / polyneuropathy, renal failure.
Measured: 01/2019- 12/2025
Administration of immunosuppressants
Administration of immunosuppressants like corticosteroid, chemotherapy, monoclonal antibodies within the last 3 months.
Measured: 01/2019- 12/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start10 Jul 2024
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511622
- Sponsor's protocol ID
- ARDS-Infectio
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immune Status on Secondary Infections in Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT06511622
- Acronym / sponsor ID
- ARDS-Infectio
- Conditions
- ARDS
- Keywords
- ARDS, ECMO, Herpes viridae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective observational study over the period 1/2019 - 02/2024 with the aim of identifying patients with a predisposition to secondary infections.
Detailed description
As a reference center, Charité Universitaetsmedizin Berlin has been treating patients with the most severe form of acute respiratory failure, known as acute respiratory distress syndrome (ARDS), for more than 30 years. Despite lung-protective forms of ventilation and the use of extracorporeal procedures for oxygenation and decarboxylation (ECMO), mortality is around forty percent. In addition to the primary cause of ARDS, further infectious complications often develop during the course of the disease, which delay recovery.
The aim of this study is to investigate infectious complications (ventilator-associated pneumonia, reactivation of Herpes viridae, pathogen resistance despite formally correct therapy, fungal infections) depending on the immune status.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female patients who received intensive care treatment for acute respiratory distress syndrome on ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days.
Key inclusion criteria (2 listed)
- Male and female acute respiratory distress syndrome patients who had an immune status within 48 h of admission
- Patients who received intensive care treatment for acute respiratory distress syndrome ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Herpes simplex reactivation
Time frame: 01/2019- 12/2025
semi-quantitatively with Herpes simplex (negative / slightly positive / positive and strongly positive) in blood or bronchial lavage
Cytomegalovirus reactivation
Time frame: 01/2019- 12/2025
as absolute copy number per milliliter of blood or bronchioalveolar lavage
Epstein Barr virus reactivation
Time frame: 01/2019- 12/2025
absolute copy number per milliliter of blood or bronchioalveolar lavage
B cells (CD19 positive)
Time frame: 01/2019- 12/2025
Absolute number per nanoliter and percentage of lymphocytes
Natural killer cells Cells (CD16 pos)
Time frame: 01/2019- 12/2025
Absolute number per nanoliter and percentage of lymphocytes.
T helper cells (CD4)
Time frame: 01/2019- 12/2025
Aabsolute number per nanoliter and percentage of lymphocytes
Cytotoxic T cells (CD8)
Time frame: 01/2019- 12/2025
Absolute number per nanoliter and percentage of lymphocytes
HLA-DR expression on monocytes
Time frame: 01/2019- 12/2025
in molecules per cell
18 secondary outcomes
Beginn weaning
Time frame: 01/2019- 12/2025
Extracorporeal membrane oxygenation duration
Time frame: 01/2019- 12/2025
Costs of treatment
Time frame: 01/2019- 12/2025
Pathogen persistence after guideline-compliant therapy (yes/no)
Time frame: 01/2019- 12/2025
Ventilator-associated pneumonia (yes/no)
Time frame: 01/2019- 12/2025
Occurrence of fungal pneumonia (yes/no)
Time frame: 01/2019- 12/2025
Mortality
Time frame: 01/2019- 12/2025
Sequential Organ Failure Assessment (SOFA score)
Time frame: 01/2019- 12/2025
Simplified Acute Physiology Score (SAPS II)
Time frame: 01/2019- 12/2025
Pre-existing conditions
Time frame: 01/2019- 12/2025
Concomitant infections with therapy
Time frame: 01/2019- 12/2025
Volumes
Time frame: 01/2019- 12/2025
Ventilation parameters
Time frame: 01/2019- 12/2025
Catecholamine doses
Time frame: 01/2019- 12/2025
Number of catecholamine days
Time frame: 01/2019- 12/2025
Recording of end organ damage such as liver and kidney failure
Time frame: 01/2019- 12/2025
Diagnoses during the intensive care stay
Time frame: 01/2019- 12/2025
Administration of immunosuppressants
Time frame: 01/2019- 12/2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Herpes simplex reactivation (time frame: 01/2019- 12/2025). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.